disaster research response project interagency briefing · overview of the nih disaster research...

National Institutes of Health • U.S. Department of Health and Human Services

Disaster Research Challenges and Opportunities

4th Annual

NIEHS Disaster Research Response

Federal Interagency Meeting

March 10, 2017

Natcher Conference Center, Rm. D

NIH Campus

National Institutes of HealthU.S. Department of Health and Human Services

Lurie, Manolio, Patterson, Collins, & Frieden. New England Journal of Medicine. 368; Mar 2013

Welcome & Introductions

“The knowledge that is generated through well-designed, effectively executed research in anticipation of, in the

midst of, and after an emergency is critical to our future capacity to better achieve the overarching goals of

preparedness and response: preventing injury, illness, disability, and death and supporting recovery.”


Today’s Meeting Goals

• Share 2016 disaster research activities that advanced infrastructure & processes

• Continue to refine a collective vision for a “National Disaster Research” capability

• Discuss opportunities for:

– Integration

– Empowerment

– Engagement

– Training

– Funding


Agenda

• 12:45-1:00 HHS/ASPR Science Preparedness

• 1:00-2:30 Advancing Disaster Research

• 2:30-2:45 Break

• 2:45-4:15 Vision for Federal Research

• 4:15-4:30 Moving Forward


HHS ASPR Science Preparedness

HOW SCIENCE CAN SAVE

LIVES: PREPAREDNESS AND

RESPONSE IN DISASTERS

Federal Interagency Meeting on Disaster Research

March 10, 2017

Leremy Colf

HHS/ASPR Director of Disaster Science

Resilient People. Healthy Communities. A Nation Prepared.

Major Disaster Declarations

1953-2014


Timeline: Major Public Health Emergencies

2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016

H5N1

9/11 andAnthrax attacks

Hurricanes Katrina, Rita,

Wilma

Hurricanes Ike/Gustav

Haiti Earthquake

Deepwater Horizon Oil Spill

Japan Earthquake/ Fukushima

2011 Tornados

Isaac and Sandy

H7N9

Boston Bombing

Ebola

Sandy Hook Shooting

MERS

OR Comm. College

Shooting

WV Chemical Spill

Flint, MIWater Crisis

Zika

H1N1

LA Floods

Hurricane Matthew


Why Does Research Matter for Disaster

Preparedness and Response?

• Recent disasters have revealed gaps in information needed to

respond effectively-- and missed opportunities to fill those gaps

• Science response aims to rapidly and effectively execute (or

begin) research to resolve critical questions about the event

• Infrastructure for science response is needed

• Barriers to effective execution of research need to be

addressed in advance of an event

•Using science to address gaps will not only improve the current

response, but make us better prepared for future disasters


Examples from Recent Disasters: Zika Virus

What were some of the science successes?

Identifying vector issues Determining link between infection and

microcephaly Identifying priority groups for vaccination

and treatment

Where could we have done better?

Developing diagnostics Understanding alternate routes of

infection Long-term care for affected infants Addressing the treatment needs of

pregnant women


What Can We Do?

Research

Operations Policy

1.Address known gaps

ahead of time

2.Facilitate research in a

crisis

3.Develop and maintain

strategic partnerships


Questions

Contact Information:

Leremy Colf, PhD

Director of Disaster Science

Email: [email protected]

Phone: (202) 205-5784

mailto:[email protected]


Advancing Disaster Research


Exploring Disaster Research Challenges & NeedsNIH Disaster Research Response Workshop: June, 2014

“Enabling Public Health Research During Disasters”

• Co-Sponsored by NIH, ASPR, CDC, IOM

• Frame a national research agenda & action items

• Integrate research into existing response structures

• Identify critical research needs & priorities

• Identify obstacles & barriers to research

• Discuss structures & strategies needed for deployment

• Share ideas, innovations, technology to support research

• Explore data collection tools & sharing mechanisms

*http://www.nap.edu/catalog.php?record_id=18967

Provided a springboard for development of NIH DR2 Program efforts


Overview of the NIH Disaster Research

Response (DR2) Program

1. Improved access to data collection tools for researchers

2. Improved NIEHS & partner capability to quickly collect data

3. Trained researchers versed in disaster tools and issues

4. Integration into planning and emergency response systems

5. Research process including public health, academia, and impacted workers and communities

Improving Disaster Responses, Reducing Health Impacts, and Preventing future harm through:


Disaster Research Model: 4 Focus Areas &

Objectives Efforts to overcome challenges and to facilitate timely research

•Data Collection & Mgmt

•Medical Tests & Samples

•Logistics

•Training

• Integration in Response

• EHS Research Network

• Community partners and other stakeholders

• IRB Review

• Funding

• Site Access

• OMB Review

• NAS Forums and Committees

• EHS Subject Matter Experts

• Community Concerns

• NIH, HHS, OSTP Groups

Research Issues

Identification & Prioritization

Research

Process

Issues

Infrastructure &

Implementation Challenges

Relationships, Integration & Coordination


Issue Identification and Prioritization

• What efforts exists to improve our capacity to identify important research issues and data gaps in response to a disaster?

• How do you currently acquire or collect this information?

• What progress have you made in developing a research agenda or gap analysis?

• How does your agency determine what research needs to be pursued?


Research Process Issues

Efforts to work through research “process” needs for developing or implementing a research response?

• Process for human subject ethical considerations?

• Process for OMB / Paperwork Reduction Act issues?

• How has your agency funded disaster research?

• Intramural?

• Extramural?

• How does your agency implement research?

• Who participates?

• Are they trained?

• How do you gain access to sites/populations to implement research?

PUBLIC HEALTH EMERGENCY RESEARCH

REVIEW BOARD (PHERRB) UPDATE

Julia Slutsman, PhD

NIH, Office of Human Subjects Research Protections (OHSRP)

What Is the PHERRB?

• Department of Health and Human Service (DHHS)

established the Public Health Emergency Research

Review Board (PHERRB) in 2012 to provide centralized,

rigorous and expeditious human subject protections

review of research studies addressing public health

emergencies (PHEs)

• Mechanism to allow researchers conducting public health

emergency research to request review by one of the NIH

intramural IRBs

• Leverages IRBs’ subject matter and regulatory expertise

• Any NIH intramural IRB can serve as the PHERRB

2

What does the PHERRB do?

• PHERRB will serve as IRB of record conducting human

subject protections review for public health emergency

research (PHER) studies; can serve as a single IRB

•provides human subject protections/regulatory review only

• Criteria for PHERB Review:

• PHER protocols conducted, supported, or regulated by

HHS, and on a case by case basis - other agencies and

sponsors;

• protocols are generally multisite; single site studies may

be reviewed on a case by case basis

• protocols subject to 45 CFR 46 and/or 21 CFR 50 and 56

3

Planned PHERRB Objectives

• Conduct strategic planning with stakeholders internal and

external to NIH to align with overall science preparedness

priorities and develop 3-5 year strategic plan

• Integrate PHERRB into HHS-wide science preparedness

planning efforts

• Integrate PHERRB operations into NIH intramural

implementation of the sIRB policy and conduct evaluation

of the PHERRB

• Position PHERRB as first stop for investigators grappling

with human subjects protections issues in public health

emergency research

4

Current Activities

• Engagement with NIEHS DR2 and other initiatives

• Piloting of PHERRB in the context of HHS Public

Health Medical Counter Measures Enterprise

(PHEMCE)

• Exploring emerging reliance agreement templates

5

Planned Activities - 2017

• Develop and/or refine PHERRB business processes

• Review first protocol, publish manuscript describing initial

PHERRB experience

• Create listing of key science preparedness stakeholders

across ICs and Federal partners

• Engage with stakeholders to elicit expectations and priorities

• Identify and engage IRBs routinely reviewing public

health emergency research (PHER)

• Explore funding resources for workshop of IRB Chairs

to discuss best practices and challenges

• Mobilize network of IRBs with capacity to review

PHER for sharing of best practices, research into IRB

review processes, etc.

6

Contact the PHERRB

PHERRB Mailbox: [email protected]

NIH Office of Human Subject Protections Research (OHSRP),

Dr. Lynnette Nieman, Director

Website: http://ohsr.od.nih.gov/OHSR/index.php

Phone: (301)402-3444

7

mailto:[email protected]

http://ohsr.od.nih.gov/OHSR/index.php

National Institutes of Health • U.S. Department of Health and Human Services

Brief Update on the NIEHS Working Group

Joan Packenham, Ph.D.

Director, Office of Human Research Compliance (OHRC)

NIEHS IRB Vice-Chair

National Institute of Environmental Health Sciences


NIEHS Role in Disaster Response

NIEHS IRB Experienced in Disaster Research Review

• Reviewed: “HEAL Study” (Katrina) and “Gulf Long-Term Follow-Up Study” (Gulf Oil Spill)

• Disaster Related IRB Training Workshops

• Consultation with local IRBs

• IRB review and provisional approval of RAPIDD

2014 Development of the ”Rapid Acquisition of Pre and Post – Incident Disaster Data Study” (RAPIDD)

• Allows for early data collection during the response phase of a future disaster

• “Plug and Play” protocol (Umbrella Protocol)

• Pre-approved generic protocol


IRB Review Challenges in Disaster Research

• Not business as usual

• Lack of best practices/guidance

• Concerns regarding expertise and qualifications of researchers

• Concerns regarding research interference

• Situational context on the disaster and the community impact

• Concerns regarding participant & community vulnerability and burden

Photos from Dr. Pamela Jenkins, University of New Orleans slide set

“What makes disaster research unique is the circumstances in which otherwise conventional methods are employed. Put differently, it is the context of research not the methods that makes disaster research unique.” (R Stallings, 2002)


Special Considerations & Best Practices for IRB

Review of Disaster Research Working Group

Purpose:

• To have an open & transparent discussion of human research protection issues in the context of disaster research

• To identify recommendations that would be instrumental in preparing and guiding IRBs to efficiently review protocols related to public health emergencies and disasters

Mission / Outcome:

• The development of special considerations for the NIH Human Research Protection Program and for IRBs who review public health emergency/disaster protocols


Inaugural Working Group Meeting

July 2016

Specific Aims

• Preparing IRBs for the review of disaster related protocols

• Outline duties of the IRB in the rapid review of research involving disaster-affected communities

• Identify participant burden for vulnerable populations after disasters

• Explore vulnerability as it relates to potential research participants and disaster communities

60 WG Members in 23 States

Breakout Groups Responded to 5 Disaster Scenarios


Working Group Recommendations

1. Preparing IRBs for Reviewing Disaster Research

2. IRB Responsibilities & Review Processes

3. Identify and Minimize Participant Burden

4. Address Research Participant Vulnerability and Informed Consent


Future Directions

• Publication of Recommendations 2016 Working Group Meeting (coming)

• Development of disaster-related IRB training modules for IRBs and PIs

• Creating a toolkit of resources for IRBs and PIs to facilitate review of

disaster protocols

• Reconvening of the working group to provide continued guidance on

ethical dilemmas associated with disaster research

• Providing expert consultation to IRBs regarding review of disaster

research

• Creating a central registry of studies


Infrastructure to Support Implementation

What efforts exists to build infrastructure to help support implementation of a disaster research response?

• What is the spectrum of infrastructure currently developed?

– Guidance & Support Information

– Surveys, Questionnaires, Protocols, Forms

– Training

– Personnel

– Equipment (e.g., medical testing, environmental sampling, PPE)

– User Availability (Intramural only? Extramural? Public access?)

Data Science @ NIH

Disaster Research @ NIH

Backbone/Functional Platform

NIH Resources

DIMRC

DR2

Literature

• PubMed

• PubSci

• Disaster Lit

Data

• Tools/Surveys/Instruments

• DataSets

• Common Data Element Repository (for standardization)

Disaster Health Information Types

Peer-reviewed scholarly literature• Journal articles

• Books

• Data

“Grey” Literature• Reports

• Guidance documents

• Summaries

• Surveillance data

• Training materials

• Conference proceedings

• Databases

• Datasets

37

Open Access Repositories for

Scholarly Literature

• PubMedCentral

• All HHS agencies

• NASA

• NIST

• EPA

• DHS

• Other Repositories• Agriculture: PubAg

• Defense: DTIC

• Energy: PAGES

• Transportation: NTL

• NOAA: NOAA Repository

• NSF: NSF Repository

• USGS: USGS Publications Warehouse

Disaster Medicine and Public Health Database:

http://disasterlit.nlm.nih.gov

Supplements PubMed

Types of Resources:

Guidance documents

Training Tools

Webinars

Meeting reports

Refine Your Results:

Source

Publication Type

Year

Author

Data Science @ NIH

• NLM to be epicenter for data science @ NIH

• NLM Director is Acting NIH Director for Data Science

• Purpose of data science is to accelerate discovery

• What data to collect? All pictures of your kids or a select

set in an album?

• Just as NLM determines what literature to select; will need

to determine what data to collect and preserve

Data Science @ NIH

Follow the FAIR Principles

Findable,

Accessible,

Interoperable,

Reusable

• PubMed Central to accept datasets in Fall 2017

• ClinicalTrials.gov already contains research results

• Promote Standards

Common Data Element Repositoryhttps://cde.nlm.nih.gov

A repository for electronic data capture instruments

and forms recommended or required by NIH

institutes and centers

• Search and find tools

• Export existing tools

• Build your own tool

• Standards

• SNOMED CT, LOINC, RxNORM

https://cde.nlm.nih.gov/

Common Data Element Repositoryhttps://cde.nlm.nih.gov

https://cde.nlm.nih.gov/


Building Infrastructure for Research Response: Repository Surveys, Questionnaires, Protocols, Guidance, Forms

• New tools identified from new literature review (2013-2016) and are in process of being added to the online repository

(n=287)

134

74

43

33

33

28

16

13

0 20 40 60 80 100 120 140 160

Mental Health/Cognitive Function

Lifestyle/Quality of Life

Specific Disasters

Social Support/Resiliency

Specific Body Systems

Occupational Health

Environmental Exposures

Preparedness

Current Number of Tools by Type


NIH DR2 Tools - Compiling Metadata for Repository

• Short Description and # of Items

• Purpose and Uses

• Mode of Administration

• Time to Administer

• Population of Interest

• Existence of Validity Studies

• Languages/Reading Level

• Special Interviewer Training

• History of Use in the Disaster Setting

• Professional Admin Requirements

• Ease of Use in Disaster

• Availability

Improvements under way:

• Tools: downloadable files (MS Word & EpiInfo) for paper or electronic entry

• Improved searching and sorting into categories

• Creation of Survey Builder functionality using EpiInfo


Rapid Acquisition of Pre/Post Incident Disaster

Data (RAPIDD) Protocol

• Reduce the time it takes to initiate data collection

– Pre-reviewed by IRB (NIEHS IRB provisional approval granted May 2015)

– Standardized methods using established instruments

– Pre-positioned study documents, questionnaires, supplies, and staff

• Initial Goal: Timely research of cohorts involved in disasters

– Contact information for cohort development

– Gather early survey information


IRB Approval Before Initiating Study

• Specifics of the disaster submitted to IRB for approval before starting study

– Research setting

– Sample size

– Accrual duration

– Procedures

– Questionnaires

– Outcomes of interest

Grantee Protocols:

- UTMB

- University of Iowa


Developing Training Materials, Field Guides, Go Kits

Biospecimen Collection


BREAK

Watch the DR2 Video from 2016

https://tools.niehs.nih.gov/wetp/index.cfm?id=2574#DR2

https://tools.niehs.nih.gov/wetp/index.cfm?id=2574#DR2


Creating the Vision for Federal Disaster Research


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INTEGRATION

National Frameworks

Laws

Policies

Guidelines

Protocols

Bench ResearchClinical Research

Field ResearchSystems Research

Collaboration

Coordination

Communication

Vision: Science-based Disaster

Preparedness, Response, and Recovery

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Vision: National Disaster Research Framework

• Guide coordination of cross-agency resources

• Develop polices & procedures for research responses

• Facilitate time-critical disaster research through strategic funding & infrastructure development

• Allow for integration into National Response & Recovery Frameworks

• Allow for the development of trans-disciplinary research enterprise focused on supporting disaster preparedness, response, & recovery

• Create cross-disciplinary training & sustainable career paths


Facilitated Discussion: Moving Forward

Short & Longer Term Opportunities

Integration

Coordination

Collaboration

Communication


Empowerment

• Processes to collectively understand research needs & gaps?

– Website and platforms for all to use to support research?

– Shared publications /articles on Disaster Research?

• Besides grants and posting of tools, how do we empower others to conduct disaster research?

– Which groups are we targeting?

– How do we measure our efforts? How do we go from theory to practice?

– How do we incorporate technology to empower and engage?

– Should we develop a “best practices” document for use by others?


Engagement of Stakeholders

• Who are the NGO stakeholders most likely to engage?

• What is in it for them?

• Is our engagement one of support, or something else?

• Do we have best practices for engagement?

• What progress have we made with citizen science?

• How do we promote local and private industry engagement?

• How to engage healthcare facilities & how to share patient data?

• How do we measure the impact of our engagement efforts?

• What are the goals and objectives for engagement?


Variety of Collaborations- Citizens & Researchers

• Environmental Measurements

• Community & Personal Exposures

• Research

• Education

• Technology

• Individual Health

Great backyard

bird count


Training

• How do we train and assist researchers (intramural & extramural)?

– Understanding emergency response management ?

– Effective integration into response organization(s)?

– Health and safety?

– Effective use of tools, protocols, data management, risk communications?

• Who needs training?

• What is the curriculum?

• How is training best delivered?


Extramural Funding

• Can disaster research be written into grants, incl. SBIR?

• How can funding be coordinated across departments?

• Funding examples:

– NSF Smart and Connected Health FOA

– NSF RAPID funding mechanism

– NIH mechanisms, supplementals, contracts

– CDC fast track funding mechanism


Next Steps

• On-going communications with this group

• Common Disaster Research Briefing Slides

• Disaster Research Best Practice Guidance Document

• Other


Thank You!

http://dr2.nlm.nih.gov/

http://dr2.nlm.nih.gov/

disaster research response project interagency briefing · overview of the nih disaster research...

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